FDA.reportPublic FDA data

Application 220071

Type
ANDA
Sponsor
VIWIT PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo
002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220071-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19
A220071-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220071-001AP
A220071-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220071-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220071-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A220071-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220071-002AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-002AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Aruba Aloe AlcoholadaLIDOCAINE HYDROCHLORIDEAruba Aloe Balm NVf56c62b0-75db-4499-858e-54e10b0e140a2025-08-07WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDELannett Company, Inc.c3353e08-2a8c-4ace-ba89-114f7131b8de2025-08-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEAurobindo Pharma Limitedab461805-413a-4fb3-88a1-224e1c4230842025-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.845b96c1-36a3-431f-8316-112ae881d9342025-07-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.767374af-89d1-4c19-bd8e-480699b45cf72025-06-11Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
XylocaineLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.25370b0f-0ac6-4a03-abe6-d73d651921802025-05-31Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.75d17334-6876-42d0-8a02-82669d139e4f2025-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHuons Co., Ltd.8ec2d256-fc4f-44f6-bee2-eef2bf3bf5802025-05-09Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.5523fdfe-69fd-49a5-b51f-73e2223d49a92025-05-01Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLC4dd52202-8eef-4136-92dd-ada573b7cf742025-04-22Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEXttrium Laboratories, Inc.31a5a48e-27d7-90f3-e063-6294a90a2d9e2025-03-31Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCcddb2b22-fce3-8967-6e54-dca3df5ac4b32025-03-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.abf60c5c-66df-4894-aa8f-bf770a6e9d002025-03-24Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.037764d3-da0e-5ebb-e063-6294a90ab6e02025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.